FDA.reportPublic FDA data

Instrument Adapter, Starlock V2012

Primary DI
04056481005368
Brand
Instrument Adapter, Starlock V2012
Company
Brainlab SE
Model
55085
Catalog number
55085
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLDInternal Polymerase Chain Reaction Control, Not Assay Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLDInternal Polymerase Chain Reaction Control, Not Assay SpecificClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122011000NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAPBrainlab AG2012-11-15OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481005368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481005368040564810053684056481005368

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14
04056481141981HIP77.02020-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540952760DSQ Alert® Internal Control set IC1 Elitechgroup Mdx LLCOLD2024-10-24
03661540952791DSQ Alert Internal Control set IC1 Elitechgroup Mdx LLCOLD2024-07-29
03661540952098DSQ Alert™ MS2-ICB-1 Internal Control SetElitechgroup Mdx LLCOLD2023-09-21
03661540951992MGB Alert MS2 RNA Internal Control in TE-Yeast RNAElitechgroup Mdx LLCOLD2023-03-06
03661540952555DSQ Alert Internal Control Set IC2Elitechgroup Mdx LLCOLD2022-12-12
03661540952333MGB Alert® Internal Control set IC1 DSQElitechgroup Mdx LLCOLD2022-09-30
03661540952364MGB Alert® Internal Control set IC1 DSQElitechgroup Mdx LLCOLD2022-09-30
03661540952388MGB Alert IC1 Internal Control Template Elitechgroup Mdx LLCOLD2022-08-30
03661540952395MGB Alert IC2 Internal Control Template Elitechgroup Mdx LLCOLD2022-08-30
03661540952401MGB Alert IC2 Internal Control Template (250uL volume)Elitechgroup Mdx LLCOLD2022-08-30
03661540952418MGB Alert MS2 Internal Control DNA Template (250uL volume)Elitechgroup Mdx LLCOLD2022-08-30
03661540952425MGB Alert MS2 Internal Control RNA Template (480uL volume)Elitechgroup Mdx LLCOLD2022-08-30
03661540952371MGB Alert IC1 Internal Control Template (35uL volume)ELITECH GROUP INC.OLD2022-07-05
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25ELITECH GROUP INC.OLD2022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100ELITECH GROUP INC.OLD2022-04-04
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25ELITECH GROUP INC.OLD2022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100ELITECH GROUP INC.OLD2022-04-04
03661540950032MGB Alert Internal Control Set IC2-BH 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540950124MGB Alert Internal Control Set IC2-B, 09N38-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950155MGB Alert Internal Control Set IC1, 09N39-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950186MGB Alert Internal Control Set IC1-A, 09N40-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950247MGB Alert Internal Control Set IC2-TElitechgroup Mdx LLCOLD2020-09-15
03661540950254MGB Alert Internal Control Set IC2-T, 09N42-001Elitechgroup Mdx LLCOLD2020-09-15
03661540950322MGB Alert Internal Control Set IC2-8 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951237MGB Alert Internal Control Set IC1-L 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951404MGB Alert Internal Control Set IC1 -480rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951411MGB Alert Internal Control Set IC2-480 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951428MGB Alert Internal Control Set IC2-B, 480 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951435MGB Alert Internal Control Set MS2-M 48 rxnElitechgroup Mdx LLCOLD2020-09-15
03661540951442MGB Alert Internal Control Set MS2-EElitechgroup Mdx LLCOLD2020-09-15